Novo Nordisk Launches Vagifem(R) 10??g , The Lowest Dose Of Local Oestrogen Available For Post-Menopausal Women With Vaginal Atrophy

Almost half (45%) of post-menopausal women suffer or have suffered from vaginal atrophy,
manifested as vaginal discomfort, increased tendency of infection, and pain during sexual
intercourse1. But only a fraction actually receives the most appropriate treatment for the
underlying cause - oestrogen deficiency. One reason is concern about the risk of excessive
oestrogen exposure. With most recent treatment guidelines there is a move towards
advocating the use of lower dose oestrogens to treat vaginal atrophy2.


This trend has led to a new product being introduced by Novo Nordisk. The company, which
markets a 25??g oestrogen vaginal tablet, has just launched the first ultra low dose local
oestrogen - it contains just 10??g of oestrogen. This helps meet the changing needs of patients
and healthcare professionals for products that limit oestrogen exposure but still provide
symptom relief. Clinical data demonstrates that the 10??g product relieves symptoms3, yet
notably, circulating oestrogen remains within normal post-menopausal levels4.


Esben Bruun Mortensen, Director of Biopharm, Novo Nordisk Limited, commented on the
launch, saying 'vaginal atrophy is a big issue for women, affecting around 40% of them at any
one time. It has negative consequences for sexual intimacy and self-esteem. Some women
mistakenly attribute symptoms to other conditions such as thrush or bladder infections, and
use treatments such as lubricants and moisturisers in an attempt to help them cope with their
symptoms. This fails to treat the underlying cause. Others are reluctant to take an oral
hormone replacement therapy (HRT) or patch because of concerns about excessive oestrogen
exposure. The arrival of the first ultra low dose 10??g local oestrogen provides a step forward
for patients and healthcare professionals. It provides effective local oestrogen replacement
directly into the vagina, whilst minimising oestrogen exposure, in line with the latest expert
guidelines'.


Notes:


Vaginal atrophy


Vaginal atrophy (VA) sometimes known as 'Atrophic vaginitis', is the thinning and inflammation
of the vaginal walls due to a decline in oestrogen caused by the menopause. Symptoms
include vaginal dryness, vaginal discomfort due to inflammation, itching, increased tendency of
infection and pain during sexual intercourse.


Development of Vagifem® 10??g


Vagifem® 10??g was approved by the European Member States on 18 January 2010. Its
approval was based on a randomised, placebo-controlled 52-week multicentre trial,3 which
found statistically significant improvements in VA symptoms with the 10??g preparation versus
placebo, including:















- Vaginal Maturation Index and Value, starting from wk 2 (p